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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Subsystem, Water Purification
510(k) Number K822385
Device Name EXTRAPURE REVERSE OSMOSIS WATER UNIT
Applicant
Extracorporeal Medical Specialities, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Extracorporeal Medical Specialities, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.5665
Classification Product Code
FIP  
Date Received08/09/1982
Decision Date 10/13/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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